The FDA has pulled Budeprion, a generic version of Wellbutrin made by Teva Pharmaceuticals, from the US market. The generic drug has been used to save patients money while treating depression, anxiety, and symptoms of nicotine withdrawal.

The move is a sharp turn from the FDA’s stance in 2009 that, despite concerns from doctors and patients, that Budeprion was chemically the same was Wellbutrin.

Budeprion’s removal comes amid a flurry of concern about the FDA’s standards regarding drug safety, and its stance that generic drugs are the same as their more expensive brand-name counterparts. According to the FDA’s website, “[Generic drugs] are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

In the case of Budeprion, the FDA’s reversal is a major victory for consumers. Millions of Americans were switched from Wellbutrin to Budeprion, sometimes without consent. Although these patients represented only about 2% of the US market for the drug, the FDA took a strong stance on the drug’s ineffectiveness.

FDA’s Studies Show Budeprion Ineffective

According to the FDA, Budeprion is ineffective because it releases its key ingredient faster than Wellbutrin. The brand-name antidepressant uses a chemical membrane to allow the drug to seep into the bloodstream over time. The generic created by Teva Pharmaceuticals uses an erodible matrix, and the pill is larger and more oblong, which makes it break apart.

The FDA completed a study comparing Budeprion to Wellbutrin in 24 adults in August, and notified Teva Pharmaceuticals last month of its findings. The administration admitted that the incorrect ruling was based on initial tests of the 150 milligram version of Budeprion. Complains came in regarding the 300 milligram version of the generic.

The other producers of generic versions of Wellbutrin – Activis, Anchen, Mylan, and Watson – have been ordered to carry out tests to ensure that their medications meet the FDA’s standards for dosage, strength, and quality.

The FDA has also come under heavy fire lately for a slew of lawsuits levied against drugs and devices that it initially improved. Among the most famous are transvaginal mesh, Actos, and DePuy’s Pinnacle and ASR all-metal hip replacement devices. Transvaginal meshwas approved for use for pelvic organ prolapse and stress urinary incontinence in women, through a loophole in the FDA approval process called 510(k), which allows devices to “fast track” to approval based on similarities to one original device. In this case, the original device that transvaginal mesh devices are based on was found to be faulty in 1999 and recalled by the manufacturer. Actos, a brand-name drug manufactured by Takeda Pharmaceuticals to treat Type 2 diabetes, has been linked in several studies since 2011 to an increase in risk of bladder cancer. The link was so strong that last summer, France and Germany both banned the drug from their markets. Finally, DePuy all-metal hip replacement devices are the subject of a variety of lawsuits because the devices, despite claims from the manufacturer, fail sooner than devices made from other materials, and cause harmful side effects such as tissue degradation and metallosis.

The Strom Law Firm Can Help with Your Budeprion Personal Injury Lawsuit

If you have been harmed by a drug or medical device such as Budeprion, your quality of life and ability to work could suffer. You may be entitled to compensation for lost wages and medical bills incurred from the error. The attorneys at the Strom Law Firm can help. We handle all kinds of personal injury cases, including:

The Strom Law Firm handles all types of personal injury cases including:

tractor trailer accidents,

automobile accidents,

burn injuries,

brain injuries,

motorcycle accidents

construction type accidents,

defective products arising from medical devices,

toys and childrens’ products,

medical malpractice claims,

nursing home neglect and abuse,

slip and fall,

wrongful death, as well as

injuries sustained while working on the job.

The attorneys at the Strom Law Firm collectively have over 30 years of legal experience, including personal injury lawsuits and defense. We are based in Columbia, SC, and are licensed to practice throughout South Carolina, Georgia, and New York. We can help you get the compensation you deserve, so contact us today for a free consultation by calling (803) 252-4800.

Centrally located in Columbia, South Carolina, the attorneys at the Strom Law Firm, L.L.C. represent clients in a variety of civil and criminal matters. We handle cases throughout South Carolina including Columbia, Lexington, Florence, Camden, Aiken, Charleston, Orangeburg, Irmo, Gilbert, Red Bank, Blythewood, Gaston, West Columbia, Chapin, Rock Hill, Saluda, Lancaster, Sumter, Spartanburg, Newberry, North Augusta, Batesburg-Leesville, as well as cases in Richland County, Lexington County, Fairfield County, Kershaw County, York County, Newberry County, Calhoun County, and Sumter County. The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. We invite you to contact us and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established.